T2 Biosystems provides update on product development pipeline progress

T2 Biosystems provided an update on its new product development pipeline progress. The Company’s product pipeline is focused on direct-from-blood diagnostic tests for antimicrobial resistance, pediatric Candida infections, Lyme disease, and Candida auris. Pipeline Progress Highlights: Finalizing a 510(k) premarket notification application for the T2Resistance Panel planned to be filed with the U.S. Food and Drug Administration during the fourth quarter of 2024. The previously submitted 510(k) premarket notification to expand use of the T2Candida Panel to detect pediatric Candida infections is pending clearance with the FDA. Advanced internal validation and plans to submit a 510(k) premarket notification to the FDA to expand the use of its FDA-cleared T2Bacteria Panel to detect pediatric bacterial infections. The Company maintains its plan to launch the T2Lyme Panel as a Laboratory Developed Test; however, it now plans to build or buy its own laboratory rather than launch through a partnership. Pursuing non-dilutive funding to complete the development, validation, and clinical studies for a diagnostic test to detect Candida auris, following the completion of feasibility and early development in collaboration with the U.S. Centers for Disease Control and Prevention/ “Our team is making excellent progress developing novel diagnostics to rapidly detect pathogens directly-from-blood, including antimicrobial resistance, pediatric Candida infections, Lyme disease, and Candida auris, and we expect to launch multiple new products in 2024 and 2025,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Three of our pipeline products have received FDA Breakthrough Device designation, including the T2Resistance Panel, the T2Lyme Panel, and the Candida auris test, and we believe all four of our pipeline products will allow clinicians to achieve faster targeted treatment, reduce cost, and improve patient outcomes.”